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2014 (8) TMI 1038

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....t' and the Food Safety and Standards Authority of India is hereinafter referred to as the 'FSSAI'. The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 are hereinafter referred to as 'Labelling Regulations' and the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 are hereinafter referred to as 'Food Additives Regulations'. 3. Brief facts of the present case are that the petitioner company is primarily engaged in the business of import, distribution and sale of wide range of products that are used by manufacturers of food and beverages, dietary supplements and pet food. On 07.02.2014, the petitioner imported from Danisco France SAS "YO-MIX 305 LYO 50 DCU" (hereinafter referred to as the 'goods') which is a blend of strains of lactic acid bacteria, that is used for direct vat inoculation into milk for preparing yogurt and fermented milk products. 4. By a letter dated 06.02.2014, the petitioner notified the Additional Drugs Controller that the said goods were permitted food additives under the Food Additives Regulations and were imported for subsequent supplies to its distributors and cu....

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....le, any packaged food products which are not marked and labelled in the manner as may be specified by regulations: Provided that the labels shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the food products contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims or in relation to the place of origin of the said food products. (2) Every food business operator shall ensure that the labelling and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, does not mislead consumers." 9. It is apparent from a plain reading of Sub-section (1) of Section 23 of the FSS Act that it is mandatory that "packaged food products" be labelled or marked in the manner as may be specified by regulations. Although, the expression "food products" is not defined under the FSS Act, the expression "food" is defined under clause (j) of the Section 3(1) of the FSS Act which reads ....

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....which are not for direct consumption as food." The goods in question would be specifically included under sub-category 99.6, which covers "microorganisms and microbial preparations". 14. The goods are, admittedly, not meant for direct consumption but are intended for industrial use in manufacture of Yogurt and fermented milk products. The learned counsel for the petitioner had pointed out that Yoghurt is defined by Regulation 2.1.12:1 of the Food Additives Regulations. The relevant extract of the said definition reads as under:- "1. Yoghurt means a coagulated product obtained from pasteurised or boiled milk or concentrated milk, pasteurised skimmed milk and/or pasteurised cream or a mixture of two or more of these products by lactic acid fermentation through the action of Lactobacillus bulgaricus and Steptococcus thermophilus. It may also contain cultures of Bifidobacterium bifidus and Lactobacillus acidophilus and other cultures of suitable lactic acid producing harmless bacteria and if added a declaration to this effect shall be made on the label. The micro- organisms in the final product must be viable and abundant. It may contain milk powder, skimmed milk powder, unfermented ....

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....goods are non compliant with regulation 2.2.2:2 of the Labelling Regulations and it is, therefore, necessary to refer to the relevant clauses of regulation 2.2.2 which is quoted below:- "2.2.2: Labelling of Pre-packaged Foods In addition to the General Labelling requirements specified in 2.2.1 above every package of food shall carry the following information on the label, namely,- 1. The Name of Food: The name of the food shall include trade name or description of food contained in the package. 2. List of Ingredients: Except for single ingredient foods, a list of ingredients shall be declared on the label in the following manner:-- (a) The list of ingredients shall contain an appropriate title, such as the term "Ingredients"; (b) The name of Ingredients used in the product shall be listed in descending order of their composition by weight or volume, as the case may be, at the time of its manufacture; (c) A specific name shall be used for ingredients in the list of Ingredients:...." 19. As is, plainly, apparent from the heading of Regulation 2.2.2, the same is applicable in respect of "Pre-packaged" foods. The opening words of the Regulation 2.2.2 also indicate that the requi....

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....ld be excluded from the definition of the expression 'consumer' within the meaning of Section 3(1)(f) of the FSS Act. It, therefore, follows that products which fall under the definition of food, meant not for direct human consumption but for sale to industrial consumers for use in manufacture of articles of food, would be excluded from the definition of 'pre-packaged' or 'pre- packed food'. This, of course, does not mean that an item of packaged food, which is ready for personal consumption by persons or families, would cease to be pre-packaged food or pre-packed food if purchased by an industrial consumer. As long as packaged food contains food items, which are ready for personal consumption, the same would fall within the definition of pre-packaged or pre-packed food. And, items that are not meant for direct consumption by individuals would fall completely outside the definition of pre-packaged or pre-packed food. Applying the aforesaid tests, it is apparent that the goods in question are not items of pre-packaged or pre-packed food. 23. In view of the aforesaid, the impugned communication is liable to be set aside. The appeal filed by the petitioner bef....

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....shed/intermediary food products which will be further processed to make final product & packed as pre-packaged or pre-packed food) 1. Name of food 2. List of ingredients (Not required in case of single ingredient) 3. Name and complete address of the manufacturer 4. Date of manufacture 5. Best before or use by date or date of expiry 1. Name and address of the importer. "   26. Even though, the said guidelines may not be applicable to the goods in question, nonetheless, it is apparent that the packages in question substantially comply with the said labelling requirements except that the name and address of the importer is not printed on the package. Nutritional information is in any event inapplicable as the goods in question are lactic cultures which are to be used in manufacture of yoghurt. The goods in question being for industrial use, the logo indicating whether the goods are vegetarian or non-vegetarian is also ex facie inapplicable. 27. In the given circumstances, it is apparent that even though the Regulation 2.2.2:2 of the Labelling Regulations is not applicable, the labelling of the goods in question provides sufficient information. In addition, the petitioner....